Stapokibart

CHENGDU, China, Dec. 23, 2024 /PRNewswire/ -- Keymed Biosciences Inc. (HKEX: 02162) today announced the National Medical Products Administration (the "NMPA") of China has recently approved the supplemental New Drug Application (the "sNDA") of Stapokibart (anti-IL-4Rα monoclonal antibody, trade name: Kangyueda (康悦达), R&D codename: CM310), for the treatment of chronic rhinosinusitis with nasal polyposis. The approval is based on a multi-center, randomized, double-blind, placebo-controlled phase III clinical study to confirm the efficacy and safety of Stapokibart injection in treatment of patients with chronic rhinosinusitis with nasal polyposis. The study results showed that the data from the phase III clinical trial was positive. Compared to the placebo, Stapokibart significantly reduced nasal polyps (NPS improvement of 2.3 from baseline) and alleviated nasal congestion (NCS improvement of 0.7 from baseline) after 24 weeks. The differences were highly statistically significant (P<0.0001). Additionally, it effectively relieved rhinosinusitis, restored sense of smell, improved nasal symptoms, and enhanced quality of life. It also demonstrated a favorable safety profile. About Stapokibart Stapokibart (trade name: Kangyueda, R&D codename: CM310) is a high-efficient, humanized antibody targeting the interleukin-4 receptor alpha subunit (IL-4Rα), and is the first domestically manufactured IL-4Rα antibody drug granted marketing approval by the NMPA. By targeting IL-4Rα, Stapokibart can block both interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling. IL-4 and IL-13 are two key cytokines that trigger type II inflammation. Stapokibart has demonstrated good safety and encouraging efficacy in multiple previous clinical trials, and its treatment of the indication of moderate-to-severe atopic dermatitis in adults has been approved for marketing in September 2024. As of the date of this announcement, the new drug application of Stapokibart for the treatment of seasonal allergic rhinitis has been accepted by the NMPA. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

CHENGDU, China, Sept.12, 2024 /PRNewswire/ -- Keymed Biosciences Inc. (HKEX: 02162) today announced the National Medical Products Administration (the "NMPA") of China has recently approved the new drug application for Stapokibart (anti-IL-4Rα monoclonal antibody, trade name: Kangyueda (康悦达), for the indication of moderate-to-severe atopic dermatitis in adults. The marketing approval of Stapokibart is based on a multi-center, randomized, double-blind, placebo-controlled Phase III study, with the co-primary endpoints being the achievement of at least a 75% improvement in Eczema Area and Severity Index (EASI-75) from baseline and an Investigator's Global Assessment (IGA) score of 0 or 1 with a reduction of ≥2 points from baseline at week 16. The results showed that this trial reached the co-primary endpoints at week 16 with long-term treatment achieving sustained clinical benefits with a good safety profile. The study showed that at week 52, the rates of achieving EASI-75 for the Stapokibart group and the placebo-to-Stapokibart group were 92.5% and 88.7%, respectively. The EASI-90 response rates were 77.1% and 65.6%, respectively. The rates of achieving an IGA score of 0 or 1 point with a reduction of ≥ 2 points from baseline were 67.3% and 64.2%, respectively. Long-term treatment with Stapokibart can consistently improve dermatitis symptoms and quality of life in subjects with moderate-to-severe AD. During the maintenance period, only one subject (0.9%) experienced a relapse. In terms of safety, Stapokibart was safe and well-tolerated after 52 weeks of administration, with safety profiles consistent with those observed at week 16 and no new safety signals identified. About Stapokibart Stapokibart (trade name: Kangyueda, R&D codename: CM310) is a humanized and highly potent antibody against the interleukin-4 receptor a-subunit (IL-4Rα). It is the first domestically manufactured IL-4Rα antibody drug granted marketing approval by the NMPA. By targeting IL-4Rα, Stapokibart can lead to dual-blockade of interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling. IL-4 and IL-13 are two critical cytokines for initiating type II inflammation. Stapokibart has demonstrated good safety and encouraging efficacy in multiple previous clinical trials. As of the date of this announcement, its new drug application for the treatments of seasonal allergic rhinitis and chronic rhinosinusitis with nasal polyposis have been accepted by the NMPA. About Keymed Biosciences Inc. Keymed Biosciences Inc. (HKEX: 02162) focuses on the urgent unmet clinical needs, and is committed to providing high-quality, affordable, innovative therapies for patients in China and overseas. To accelerate the efficiency of our research and discovery, the Company has established a fully-integrated platform encompassing all of the key functions in the biological drug development which include target validation, lead molecule discovery and optimization, preclinical evaluation, process development, translational research, clinical development and manufacturing. This integrated platform has enabled us to rapidly and cost-effectively identify, build, expand and advance our diversified pipeline of innovative and differentiated antibody-based therapies, including monoclonal antibodies, antibody drug conjugates (ADCs) and bispecific antibodies. For more information, please visit . SOURCE Keymed WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED